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阿霉素治疗晚期及复发性乳腺癌的临床评估(第4号)——日本30家机构关于CAF方案治疗患者采用不同维持疗法的缓解期联合研究。日本乳腺癌阿霉素临床研究组

[Clinical evaluation of adriamycin in advanced and recurrent breast cancer (No. 4)--Joint study by 30 institutes on the duration of remission using various maintenance therapies in patients treated with CAF. Clinical Study Group of Adriamycin for Breast Cancer in Japan].

作者信息

Nomura Y, Abe O, Izuo M, Inoue K, Enomoto K, Kubo K, Koyama H, Sakai K, Terasawa T, Tominaga T

机构信息

Dept. of Breast Surgery, National Kyushu Cancer Center.

出版信息

Gan To Kagaku Ryoho. 1988 Jun;15(6):1863-71.

PMID:3382238
Abstract

In order to further extend the duration of remission induced by high-dose CAF therapy, maintenance therapies based on long-term oral administration of cyclophosphamide and fluorouracil (CF) were applied for patients with advanced and recurrent breast cancer. The duration of remission was compared by the envelope method among the basic therapy (Arm I), Arm I plus intermittent administration of adriamycin (Arm II) and Arm I plus tamoxifen from the start of high-dose CAF therapy (Arm III). The response rate of 163 evaluable patients in 30 institutes was 42.1% (27/57) and 44.4% (25/54) for Arm I and Arm II (CAF therapy). The rate for Arm III (CAF therapy) was 61.5% (32/52), a little higher than that for the other two. As side effects due to the induction therapy, alopecia, fatigue, anorexia, nausea and vomiting, and leukopenia were observed in a relatively high proportion of patients. Mean values of CR duration, PR duration and the whole duration of remission in responding patients were 14.0 approximately 21.5 weeks, 24.0 approximately 32.2 weeks and 28.0 approximately 42.6 weeks, respectively, without any significant difference among the three groups given different maintenance therapies. The mean values of survival duration in responding patients were 27.1, 22.0 and 17.2 months, respectively for Arm I, Arm II and Arm III no significant difference being recognized in this point, either.

摘要

为进一步延长高剂量CAF疗法诱导的缓解期,对晚期和复发性乳腺癌患者采用基于长期口服环磷酰胺和氟尿嘧啶(CF)的维持疗法。从高剂量CAF疗法开始,通过信封法比较基础治疗组(I组)、I组加阿霉素间歇给药组(II组)和I组加他莫昔芬组(III组)的缓解期。30个机构的163例可评估患者中,I组和II组(CAF疗法)的缓解率分别为42.1%(27/57)和44.4%(25/54)。III组(CAF疗法)的缓解率为61.5%(32/52),略高于其他两组。作为诱导疗法的副作用,相当比例的患者出现脱发、疲劳、厌食、恶心和呕吐以及白细胞减少。缓解患者的CR期、PR期和总缓解期的平均值分别约为14.0至21.5周、24.0至32.2周和28.0至42.6周,给予不同维持疗法的三组之间无显著差异。缓解患者的生存期平均值在I组、II组和III组中分别为27.1、22.0和17.2个月,在这一点上也未发现显著差异。

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[Clinical evaluation of adriamycin in advanced and recurrent breast cancer (No. 4)--Joint study by 30 institutes on the duration of remission using various maintenance therapies in patients treated with CAF. Clinical Study Group of Adriamycin for Breast Cancer in Japan].阿霉素治疗晚期及复发性乳腺癌的临床评估(第4号)——日本30家机构关于CAF方案治疗患者采用不同维持疗法的缓解期联合研究。日本乳腺癌阿霉素临床研究组
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